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The purpose of this announcement is to encourage investigators to pursue translational activities and clinical feasibility studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent clinical feasibility study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also augment their project with NIH contract research organizations that specialize in large animal testing, sterilization testing, biocompatibility assessment, manufacturing, and medical monitoring. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this NOFO or any of the companion opportunities. For more information see BP MedTech website.

The SuRE program supports research capacity building at eligible higher education institutions by funding investigator-initiated biomedical research inbasic, social, clinical, behavioral, or translational science that falls in the mission areas of the NIH. The purpose of SuRE awards is to provide support for investigator-initiated research at resource-limited institutions by full-time faculty who are not currently funded by any NIH Research Project Grants (RPGs) with the exception of SuRE or SuRE-First awards, to furnish students with high-quality undergraduate and/or graduate research experiences, and to enhance the institutional scientific research culture.

The SuRE program supports research capacity building at eligible higher education institutions through funding investigator-initiated biomedical research inbasic, social, clinical, behavioral, or translational science that falls in the mission areas of the NIH. The purpose of SuRE-First awards is to provide support for investigator-initiated research at resource-limited institutions by full-time faculty who have not had any prior independent, peer-reviewed, external research grants, to furnish students with high-quality undergraduate and/or graduate research experiences, and to enhance the institutional scientific research culture.

The purpose of the Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral (Parent F31) award is to enable promising predoctoral students will obtain individualized, mentored research training from outstanding faculty sponsors while conducting dissertation research projects in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The proposed mentored research training must reflect the candidates dissertation research project and is expected to clearly enhance the individuals potential to develop into a productive, independent research scientist. This Notice of Funding Opportunity (NOFO) does not allow candidates to propose to lead an independent clinical trial but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.

This Notice of Funding Opportunity (NOFO) will support students at institutions without NIH-funded institutional predoctoral dual-degree training programs. The purpose of the Kirschstein-NRSA, dual-doctoral degree, predoctoral fellowship (F30) is to enhance the integrated research and clinical training of promising predoctoral students, who are matriculated in a combined MD/PhD or other dual-doctoral degree training program (e.g. DO/PhD, DDS/PhD, AuD/PhD, DVM/PhD), and who intend careers as physician/clinician-scientists. Candidates must propose an integrated research and clinical training plan and a dissertation research project in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The fellowship experience is expected to clearly enhance the individual's potential to develop into a productive, independent physician/clinician-scientist. This NOFO is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial, but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.

The objective of this Notice of Funding Opportunity (NOFO) is to invite new and renewal applications for the Rare Diseases Clinical Research Consortia (RDCRC) that comprise the Rare Diseases Clinical Research Network (RDCRN). The RDCRCs are intended to advance and improve diagnosis, management, and treatment of numerous, diverse rare diseases through highly collaborative, multi-site, patient-centric, translational and clinical research. Special emphasis will be placed on the early and timely identification of individuals with rare diseases and clinical trial readiness.

The purpose of this NOFO is to invite Exploratory/Developmental Research Grant (R21) applications that propose to study the ethical, legal, and social implications (ELSI) of human genetics and genomics. Applications may propose studies using either single or mixed methods. Approaches may include but are not limited to empirical qualitative and quantitative methods, as well as conceptual, legal, and normative analyses. Direct involvement of key stakeholders where appropriate is encouraged. Of particular interest are studies that explore the implications of new or emerging genomic technologies or novel uses of genomic information.

The purpose of this NOFO is to invite Research Project (R01) applications that propose to study the ethical, legal, and social implications (ELSI) of human genetics and genomics. Applications may propose studies using either single or mixed methods. Approaches may include but are not limited to empirical qualitative and quantitative methods, as well as conceptual, legal, and normative analyses. Direct involvement of key stakeholders where appropriate is encouraged. This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application. Applications without a PEDP will not be reviewed.

The Joint NINDS/NIMH Exploratory Neuroscience Research Grant program supports exploratory and innovative research projects, which fall within the missions of the NINDS and NIMH. Awards will provide support for the early and conceptual stages of projects. These studies often assess the feasibility of a novel avenue of investigation and involve considerable risk, but have the potential to bring about breakthroughs in the understanding of important areas of neuroscience, or to the development of novel techniques, agents, methodologies, or models, of high value to the neuroscience community. While this funding opportunity also accepts clinical trials, only applications proposing mechanistic clinical trials or studies or basic experimental studies with humans (BESH) will be considered for funding. For information on the types of clinical trial that are within scope of this funding opportunity announcement, refer to Funding Opportunity Description, below.

The purpose of this announcement is to encourage grant applications for investigator-initiated prospective observational comparative effectiveness research (CER) to the National Institute of Neurological Disorders and Stroke (NINDS). The study must address questions within the mission and research interests of the NINDS and may evaluate preventive strategies, diagnostic approaches, or interventions including drugs, biologics, and devices, or surgical, behavioral, and rehabilitation therapies. Information about the mission and research interests of the NINDS can be found at the NINDS website (https://www.ninds.nih.gov/). Studies proposed should provide a cost-effective means of collecting data with a meaningful bearing on current clinical practice. Awards made under this FOA will initially support a milestone-driven planning phase (UG3) for up to 2 years, with possible transition to a observational study phase of up to five years (UH3). Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase for observational studies will permit both scientific and operational planning activities. Scientific planning activities include small-scale data collection to assess the feasibility and/or acceptability of data collection, storage, and planned analyses. Operational planning activities include, at a minimum, development of recruitment and retention strategies, case report forms, data management system and other tools for data and quality management. The UH3 phase of the award will support the conduct of investigator-initiated observational study.